USELESS
POISONS

Increasingly sophisticated and expensive cellular poisons are being given to seriously ill patients with colon, breast, lung and prostate cancer. Now an epidemiologist has analyzed the actual rate of life extension in such patients. His findings are that despite all the alleged progress, patients do not actually live a day longer.

On Christmas eve, Erika Meyer (fictitious name) was taken to ProsperHospital in Recklinghausen. Her doctors removed a malignant tumor from her colon and also removed her spleen. At the beginning of August, however, they discovered that her tumor had metastasized (spread). On Tuesday of the past week the 64-year-old homemaker began her first round of chemotherapy.

“This is a complete nightmare for me,” said Frau Meyer. “I never thought that I would one day develop cancer. But I hope that I will become better. One’s chances are always better with chemotherapy.” (Die sind ja immer weiter mit der Chemotherapie.)

At the Clinical Center of the University of Munich one scientist does not share her optimism. Epidemiologist Dieter Hoelzel, 62, says that “as far as survival with metastatic cancer of the colon, breast, lung and prostate goes, there has been no progress in the past 25 years.” He has documented the outcome of patients treated since 1978 in and around Munich, according to the standard methods of oncology. These are people suffering from the advanced stages of one of the four major internal cancers, which annually claim about 100,000 victims in Germany alone. These tumors are the big killers.

If a tumor has metastasized, and can no longer be reached by surgery or X rays, then chemotherapy is considered the treatment of last resort. For decades, a series of new cellular poisons have been used. Often drug manufacturers have also demanded astronomically high prices. In exchange, they promise a longer life.

“A chance at life!” say large billboards, each about 9 feet high, for the drug Taxotere. The manufacturer of a competing product recruits patients using the slogan “Taxol give yourself a future!” (Taxol – dem Leben eine Zukunft geben!)

However, the latest figures from the cancer registry of the University of Munich do not confirm that view. Survival rates have not improved over the past decades. Today’s patients die just as fast of their cancer as their fellow sufferers did 25 years ago. While the statistical curve for colon cancer shows a slight improvement, the survival rate for breast cancer actually fell over the course of the years.

These fluctuations probably mean nothing, said Dr. Hoelzel, except the accidental ups-and-downs of statistics without any real significance. However, he fears that the systematic expansion of chemotherapy for cancer of the breast could be responsible for the decline of the survival rate.

These statements from the Munich epidemiologist explicitly do not apply to the chemotherapy of Hodgkin’s and non-Hodgkin’s lymphoma, leukemia, sarcoma, and testicular cancer. These diseases can be cured in some cases in an almost spectacular way. Hoelzel’s verdict also does not apply to chemotherapy that is used to shrink tumors before surgical intervention (neoadjuvant chemotherapy, ed.) or to destroy stray tumor cells after an operation (adjuvant chemotherapy, ed.)

But experienced clinicians agree that the balance tips against chemotherapy when it comes to treating solid tumors in advanced stages. Gerhard Schaller, MD, 52, a gynecologist at the University of Bochum, states: “For the survival of women with advanced breast cancer, chemotherapy previously brought them practically no benefit – a lot of noise about nothing.”

Wolfram Jaeger, MD, 49, Director of Gynecology at the State Clinics of Düsseldorf, has had similar experiences. “Chemotherapy gave, and gives, no successes. Enormous numbers of women are treated, without proven benefit (ohne dass ein Nutzen tatsächlich bewiesen wäre). If we told this to the patients, however, they would totally despair.”

Millions of Patients

Millions of patients over the past 50 years have undergone chemotherapy. The first patient with an advanced lymphosarcoma (non- Hodgkin’s lymphoma, ed.) was treated with mustard gas by US physicians in 1942. The tumor shrank in an almost miraculous way. This effect disappeared after three months and the patient died. Nevertheless, this temporary success rang in the era of chemotherapy against cancer suffering.

Cytotoxic drugs are cellular poisons that intervene in a different way in the proliferation of cells. Because tumor cells divide more frequently than most other body cells, tumors and metastases are particularly susceptible to such drugs. Tumors can shrink, and, every now and then, they disappear even completely. However healthy cells, which divide rapidly, can also be damaged, including cells of the hair follicles and the blood forming cells of the bone marrow.

The question [of whether or not chemotherapy really extends life, ed.] can probably no longer be answered. In clinical studies the manufacturers always compare their new drugs with older cellular poisons. There are no control groups that are given no treatment at all.

In order to be allowed onto the market, it suffices to achieve a “statistically significant” advantage in one small group of hand- picked test subjects vs. those treated with some already approved cellular poison.

Some of the early chemotherapeutic drugs led to the premature death of patients and were removed from the market. Other patients were put through hell. They lost their hair and appetite or were plagued by serious systemic infection.

The late Klaus Thomsen, MD, long-time director of gynecology of the University Clinic Hamburg-Eppendorf, explained in September 1985, at an international congress in Berlin: “Upon reflection, we should not be surprised if an increasing number of doctors would say that they will abandon such an undistinguished form of treatment.”

Ten years later, the epidemiologist Ulrich Abel, PhD, of the University of Heidelberg, put the entire usefulness of chemotherapy in doubt. For over a year, this scientist reviewed several thousand publications on chemotherapy. He concluded that “for most internal cancers no proof exists that chemotherapy, especially the increasingly high dose variety, increases life expectancy or improves quality of life.”

Notable oncologists agreed: the expansion of chemotherapy could not stop that. But because physicians did not want to admit to their patients that they were completely defenselessly against cancer, this poisonous cure became one of the dogmas of medicine. That `benefits’ all participants: “The physicians are happy that they have something they can offer, the patients are happy, that they can take something, and the industry is happy,” says the Düsseldorf gynecologist Jaeger.

Progress mainly consists in reducing the side effects that are caused by the drugs themselves. Earlier, these cellular poisons weakened patients to such an extent that they had to be supervised in the hospital. Now, however, methods of reducing hair loss, appetite loss, diarrhea and blood clots lie at hand. Many chemotherapies can even be carried out on an outpatient basis.

Each quarter, oncologist Friedrich Overkamp uses 1.5 million Euro worth of medicines on his 1,100 cancer patients. Nationwide (in Germany) the use of the cytotoxic drugs between August 2003 and July 2004 added up to 1.8 billion Euro an increase of 14 per cent compared to the previous year. (Note: the Euro is currently worth around $1.30).

Monoclonal antibodies, which can recognize cancer cells more specifically, are the latest market drivers. Again, the drug manufacturers envision a breakthrough. Nevertheless, in this situation as well, clear proof is lacking that the lifespan of incurably ill cancer patients is truly extended. Meanwhile, competition from the new monoclonal antibodies leads to a situation in which cellular poisons are pushed more aggressively in the market.

For decades pharmaceutical manufacturers brought more new cytotoxic drugs to market; in the seventies there were just five, but in the nineties approximately 25 new drugs were approved.

“If each of these signified some small progress,” said Munich epidemiologist Hoelzel, “then this should have led to remarkable improvements over the past decades. However, we do not see that reflected in our cancer register.”

It is also difficult to find proof of a survival advantage in the thousands of reports from the drug industry. For metastatic breast cancer there are only about ten studies that suggest that a cytotoxic drug ‘cocktail’ extends life, when compared to another such mixture. Because, however, thousands such comparative studies have been performed, Heidelberg epidemiologist Abel argues that “statistically remarkable differences in a substantial number of studies are simply due to an expected coincidence.”

The proponents of chemotherapy refer particularly to two influential works. In the first of these, French researchers studied 724 female patients who had metastatic breast cancer. The three-year survival rate after diagnosis increased from 27 per cent (for those treated between 1987 and 1993) to 43 per cent (1994 to 2000).

However, the epidemiologist Hoelzel attributes this apparent improvement to a shortcoming in sampling methodology. In the period 1994 to 2000, metastasized breast cancer tended to be more promptly recognized than it was in the earlier cases (1987-1993). Because the illness had not progressed so far at first diagnosis, life expectancy was much greater. This gave the illusion of an apparent increase in survival time, although of course the apparent improvement in survival rates was not the result of any therapy.

Defenders of chemotherapy also cite a study from the University of Texas, Houston, published in August 2003. In this study, the five- year survival rate of women with metastasized breast cancer improved continuously over the years 1974 to 2000, from 10 per cent to 44 per cent. This article also contained an overview of all the cytostatic drugs, which the authors claimed had made this alleged progress possible. However, in the study in question women both with and without metastases were mixed together for comparison. The groups from more recent time were distorted by the inclusion of more female patients who had more favorable prognoses. The authors of this celebratory article actually admit that in a hidden sentence (in einem versteckten Satz).

“There is no systematic documentation at all,” says Hoelzel of such “trick research” (Trickforschung). “That is the great deficiency of cancer medicine,” complains Dr. Hoelzel. Meanwhile, with his demand for clean scientific proof, critic Hoelzel will hardly be allowed to shake up the industry. Because the industry already manages very well without any proof of the utility of drugs for patients with advanced cancer.